Official Title
Low-flow Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform for Correction of Hypercapnia in COVID-19-associated Acute Respiratory Distress Syndrome
Brief Summary

The study aims to investigate the efficacy of extracorporeal CO2 removal for correctionof hypercapnia in coronavirus disease 19 (COVID-19)-associated acute respiratory distresssyndrome

Detailed Description

The prevalence of acute respiratory distress syndrome (ARDS) caused by COVID-19 is
approximately 8%. Lung-protective ventilation is the current standard of care for ARDS.
It limits lung and distal organ impairment, but is associated with hypercapnia in
approximately 14% of patients with mild to moderate ARDS and almost all patients with
severe ARDS. In this setting, early implementing of an extracorporeal CO2 removal
(ECCO2R) therapy may prevent further escalation of invasiveness of therapy (eg, need for
extracorporeal membrane oxygenation (ECMO)). A number of low-flow ECCO2R devices are now
available and some of those can be integrated into a renal replacement therapy (RRT)
platform. This study aims to investigate the efficacy of an original ECCO2R system used
in conjunction with a RRT platform in hypercapnic patients with COVID-19-associated
mild-to-moderate ARDS with or without acute kidney injury (AKI) necessitating RRT.

Recruiting
ARDS
Hypercapnic Respiratory Failure
AKI

Device: ECCO2R

ECCO2R integrated into the multiFiltrate device

Eligibility Criteria

Inclusion Criteria:

- mild-to-moderate ARDS according to the Berlin definition

- lung-protective ventilation with positive end-expiratory pressure (PEEP) > 5 cm of
water on mechanical ventilation expected to last > 24 h

- hypercapnia <80 mmHg

- bilateral opacities on chest imaging

Exclusion Criteria:

- age < 18 years

- pregnancy

- patients with decompensated heart failure or acute coronary syndrome

- respiratory acidosis with persistent partial pressure of blood carbon dioxide (PCO2)
levels >80 mmHg

- acute brain injury

- severe liver insufficiency (Child-Pugh scores > 7) or fulminant hepatic failure

- decision to limit therapeutic interventions

- catheter access to femoral vein or jugular vein impossible

- pneumothorax

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Germany
Locations

University Hospital Giessen and Marburg, Giessen
Giessen, Hessen, Germany

Contacts

Faeq Husain-Syed, MD
+4964198542351
faeq.husain-syed@innere.med.uni-giessen.de

Istvan Vadasz, MD
+4964198542351
istvan.vadasz@innere.med.uni-giessen.de

Werner Seeger, MD, Study Director
University Hospital Giessen and Marburg, Giessen

University of Giessen
NCT Number
MeSH Terms
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Acute Lung Injury